Medical valve and methods fuse

ABSTRACT

A medical valve has a body which includes a wall structure defining an internal cavity having a proximal end and a distal end. The proximal end has an opening sufficiently large to receive a tip of a delivery end of a medical implement which transfers fluid through the delivery end. The valve also has a spike with a tip contained within the cavity and at least one hole located distal the tip. The spike has a passageway in communication with the hole that allows fluid to flow through the spike. The valve also has a resilient seal in the cavity which surrounds the spike. The seal is adapted to be moved into a compressed state upon insertion of the tip of the medical implement into the opening. The seal is sufficiently resilient to return to a decompressed state upon removal of the tip of the medical implement from the opening. In Addition, the seal has at least two tires in contact with the spike proximal the hole, preventing the flow of fluid through the valve when the seal is in the decompressed state.

This application is a continuation of U.S. patent application Ser. No.08/573,964, filed Dec. 15, 1995, now U.S. Pat. No. 5,700,248.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a closed, patient access system whichautomatically reseals after administering medication using a standardmedical implement that directly connects with the system without theneed of any intermediary needles, caps or adaptors. A two-way valveeliminating dead space is used which includes a seal which, upon beingcompressed by the medical implement, is pierced to open the valve andreseals upon being decompressed, maintaining a fluid tight seal even athigh pressures and after repeated uses.

2. Background Discussion

The manipulation of fluids for parenteral administration in hospital andmedical settings routinely involves the use of connectors and adaptorsfor facilitating the movement of fluids between two points. Most fluidconnectors and adaptors employ needles to pierce a septum coveringsterile tubing or to pierce the septum of a medicament container offluid. Fluid then passes from the container or fluid fulled tubing intoa syringe or second set of tubing. These connectors and adaptors oftenhave mechanical or moving parts. Since the ready passage of fluidsthrough the connectors and adaptors is often critical to patientsurvival, it is imperative that the connectors and adaptors functionreliably and repeatedly. Adaptors and connectors that malfunction duringuse may be life-threatening. The more mechanical or moving parts such assprings and diaphragms, the more likely that they will functionimproperly. Improper functioning can result in the introduction of airembolisms into a patient. Thus, the fewer the mechanical parts, the morethese connectors can be relied on and the better they will be acceptedby the medical community.

Many connectors or valves, especially those employing several mechanicalcomponents, have a relatively high volume of fluid space within them.This "dead space" within the device prevents the accurate introductionof precise fluid volumes and provides an opportunity for contaminationupon disconnection of the device. Connectors and adaptors often includevalves that permit or interrupt the flow of fluid along the course offluid travel. Several of those commonly in use employ metal needles topuncture sterile seals. Such connectors are generally designed toaccommodate fluid flow in one direction. This means that the fluid linemust have connectors and tube aligned in complementary directions. Theseconnectors often require further manipulation if, for example, the valveis inadvertently assembled in a direction that will not facilitate fluidflow. These manipulations increase handling, thereby increasing both therisk of contamination and the amount of time required to establish thefluid connection.

Metal needles employed as part of connector devices often havethrough-holes placed at the tip of the needle. Connection of the valvewith a flow line involves piercing the needle through a sealed septum.Through-holes placed at the needle tip can core the septum and releasefree particulates into the flow line. Such an event can prove fatal to apatient. Such through-holes may also become clogged easily with materialfrom the septum. Moreover, the use of a needle with a sharp point mayalso cause deterioration of the septum.

Reusable connectors and adaptors are preferred for medical applicationssince components must often be added or removed from a fluid lineconnected to a patient. Reusable connectors, however, are difficult tokeep sterile. Sometimes caps are employed to cover the connector to keepit sterile. Frequently, these caps are lost, or simply not used becausethey are not readily available when needed.

A closed, patient access system that is easy to use and employs only avalve device in communication with the patient that need not be cappedor interconnected with the medical implement through a needle oradaptor, is swabbable, is sufficiently durable to maintain its functionafter several manipulations, and maintains a fluid-tight seal at highpressures, would be of great benefit to the medical community.

SUMMARY OF THE INVENTION

The valve of this invention has several features, no single one of whichis solely responsible for its desirable attributes. Without limiting thescope of this invention as expressed by the claims which follow, itsmore prominent features will now be discussed briefly. After consideringthis discussion, and particularly after reading the section entitled,"Detailed Description of the Preferred Embodiments," one will understandhow the features of this invention provide its advantages, which includesafety, reliable and repeatable performance, simplicity of manufactureand use, and provides long life without malfunction.

A preferred embodiment of a seal used in the present invention comprisesa series of O-ring elements stacked together and connected to form aunitary structure. The O-ring elements have increasing diameters, withthe smallest diameter element being adjacent the proximal end of thecavity. The O-ring element closest to the proximal end of the sealcontacts the wall of the spike proximal the through-holes when the sealis in a decompressed state, thereby preventing fluid from leaking fromthe interior of the spike through the proximal opening in the housing.It is desirable that at least the next immediate O-ring element also bein contact with the spike proximate the through-holes. Such a designprevents fluid from applying enough pressure on the slit to force theslit open while the seal is in the decompressed state. With thepreferred embodiment fluid may reside in the spike and between the spikeand the seal distal the through-holes without opening the slit in theseal cap. The seal is designed so that if this fluid pushes the sealupwards slightly, lifting the first and second O-ring elements upwardsand off the spike, the O-ring elements immediately distal the first andsecond elements move up and contact the spike so as to ensure that fluiddoes not flow through the seal cap and out of the valve. Maintainingthis contact around the spike avoids having fluid pressure on the slitforce the slit open, permitting the valve to leak.

In another feature of the present invention, the housing is providedwith fluid escape space, such as a groove or channel, to permit fluidcontained between the exterior of the seal and the housing to escapeduring compression of the seal. In one embodiment, the proximal end ofthe housing is provided with at least one groove extending from theproximal end of the housing to indentations contained within thehousing. During the compression of the seal, fluid between the exteriorof the seal and the housing travels in a proximal direction through thegrooves and out of the valve through the proximal end of the housing. Inanother embodiment, a channel is provided in the fluid escape spacethrough the side wall of the housing. As the seal is compressed, fluidbetween the exterior of the seal and the housing travels through thechannel to the exterior of the valve. As discussed in greater detailbelow, providing a groove or channel to permit fluid between theexterior of the seal and the housing side wall to escape from the valveduring compression of the seal, provides several advantages.

BRIEF DESCRIPTION OF THE DRAWING

The preferred embodiments of this invention, illustrating all itsfeatures, will now be discussed in detail. These embodiments depict thenovel and non-obvious methods and valves of this invention as well asthe medical implement indicators and methods of use thereof, as shown inthe accompanying drawing, which is for illustrative purposes only. Thisdrawing includes the following Figures, with like numerals indicatinglike parts:

FIG. 1 is a perspective view of the first embodiment of a valve usefulin connection with this invention.

FIG. 2 is an exploded perspective view of the valve shown in FIG. 1illustrating spike, seal, and body or housing components of theinvention.

FIG. 3 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1.

FIG. 4 is a schematic, longitudinal, cross-sectional view of theassembled valve of FIG. 1 before compressing the seal.

FIG. 5 is a schematic, longitudinal, cross-sectional view similar toFIG. 4 showing the valve during compression of the seal.

FIG. 6 is a perspective view of a second embodiment of a valve useful inconnection with the present invention.

FIG. 7 is a longitudinal cross-sectional view of the valve of FIG. 6.

FIG. 8 is a schematic illustration of an ANSI delivery end of a medicalimplement compressing the seal of a valve.

FIG. 9 is a side elevation view, partially in cross-section, of anembodiment of the seal.

FIG. 10 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using the seal of FIG. 9.

FIG. 11 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using another embodiment of the seal.

FIG. 12 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using yet another embodiment of the seal.

FIG. 13 is a longitudinal cross-sectional view of an additionalembodiment of the seal.

FIG. 14 is a longitudinal section of the seal shown in FIG. 13 used inconnection with the spike device shown in FIG. 2.

FIG. 15 is a longitudinal partial cross-sectional view of a stillfurther embodiment of the seal of this invention.

FIG. 16 is a longitudinal cross-sectional view, after assembly, of thevalve shown utilizing the seal of FIG. 15.

FIG. 17 is a longitudinal cross-sectional view, after assembly, of thevalve shown utilizing still another embodiment of the seal.

FIG. 18 is a longitudinal cross-sectional view, after assembly, of thevalve utilizing yet one more embodiment of the seal.

FIG. 19 is a side elevation view, after assembly, of the seal and spikeshown in FIG. 14 connected to the body or housing shown in FIGS. 20 and21.

FIG. 20 is a cross-sectional view taken along line 20--20 of FIG. 19.

FIG. 21 is a perspective view of the housing shown in FIG. 19, withsections broken away to show the wall structure of the cavity containingthe seal shown in FIGS. 13 and 14.

FIG. 22 is a greatly enlarged, cross-sectional view taken along line22--22 of FIG. 14.

FIG. 23 is a longitudinal cross-sectional view of another preferredembodiment of the seal.

FIG. 24 is a partial cross-sectional view, after assembly, of the valveshown utilizing the seal of FIG. 23 and another preferred embodiment ofthe spike.

FIG. 25 is a partial cross-sectional view of the valve of FIG. 24,illustrating grooves in the housing.

FIG. 26a is a top view of the valve of FIG. 25, illustrating the groovesin the housing.

FIG. 26b is a top view of another preferred embodiment of the valve witha channel shown in phantom through the side wall of the valve.

FIG. 27 is a partial cross-sectional view of the valve of FIG. 26billustrating the channel.

FIG. 28 is a perspective view of the housing, with sections broken awayto show the wall structure of the cavity containing the seal, includingthe groove in the housing.

FIG. 29 is an elevational view of a preferred embodiment of the housingwith a channel through the housing wall shown in phantom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The term "proximal" is used to denote the end of the valve and othercomponents at or near the spike tip 32 in FIGS. 2 through 5, 10 through12, 14, 16, 24, 25 and 27, and at or near the spike tip 60 in FIG. 6,and at or near the seal cap 92 in FIGS. 8, 9, 13 through 19, 23, 24, 25and 27. The term "distal" is used to denote the opposite end of thevalve, or spike tip, or seal. The term "medical implement" is used todenote any medical tool known to those of skill in the art that canfacilitate the passage of fluids, particularly liquids, therethrough.Examples of medical implements that are contemplated include, but arenot limited to, tubing, conduit, syringes, IV sets (both peripheral andcentral lines), piggyback lines, medical valves, and other components.Medical implements are commercially available in standard sizes. Thus,either or both ends of the valve can be provided with fittings toaccommodate such standard size medical implements.

The valve is a closed, patient access system which automatically resealsafter administering medication using a medical implement that directlyconnects with the system without the need of any intermediate needles,caps or adaptors. A two-way valve is employed utilizing a reusable sealthat may be repeatedly pierced by an enclosed, protected spike ratherthan an exposed metal needle. The valve facilitates fluid, particularlyliquid, transfer while maintaining sterility. The valve is easy to useand is capable of locking in place. After use, the valve is swabbed inthe conventional manner with a suitable substance to maintain sterility.The design of the valve avoids accidental needle sticks. As will bediscussed in detail below, the valve is useful as a medical connector oradaptor to enable liquid flow from a sealed container.

The first feature of the invention is that the valve has a bodyincluding a wall structure defining an internal cavity having a proximalend and a distal end. The cavity has an open space into which the sealis pushed, and preferably has a plurality of radial indentations in thewall structure that are adjacent the seal to accommodate the expansionof the seal upon compression. The proximal end has an openingsufficiently large to receive a delivery end of a medical implementwhich transfers fluid through the delivery end. In most applications,the delivery end of the implement is tapered inward so that the wallstructure and the tapered delivery end fit snug against each other uponinsertion of the delivery end into the opening. The proximal end of thecavity preferably is adapted to fit snug with an ANSI (American NationalStandards Institute, Washington, D.C.) standard end of the medicalimplement. Typically, the implement is a syringe, a connector orinlet/outlet of an IV set, or any one of a wide variety of conduits usedin medical applications.

The second feature is that the spike has a tip with at least one holelocated at or near the tip, and a passageway in communication with thehole that allows fluid to flow through this hole. Preferably, the holeis in a side of the spike adjacent the tip and is elongated, having asize of 18 gauge or greater. More than one hole is desirable for manyapplications, and three, symmetrically located holes inward of theproximal end are preferred. The spike is seated inside the cavity andthe tip is embedded in the seal cap located at the proximal end of theseal. The tip of the spike is blunt and rounded so as to avoiddeterioration of the seal from repeated penetration by the spike. Thespike may include at least one rib which allows air to enter a spacebetween the seal and the spike, thereby facilitating the sealing of theopening when the implement is removed. The spike may have asubstantially conical shape, and the seal has a complementarily,substantially conical shaped cavity within it conforming to the shape ofthe spike.

The third feature is that the resilient seal is adapted to be moved intoa compressed state upon insertion of the tip of the medical implementinto the opening and returns to a decompressed state upon removal of thetip. The seal in the decompressed state has a section which fillsessentially completely a portion of the cavity adjacent the opening. Inthe compressed state, the seal section is pushed by the delivery end ofthe medical implement away from the opening and into the cavity. Thisseal section, known as the seal cap, may have a pre-cut slit in whichthe proximal end of the spike is embedded. The delivery end of theimplement and the seal are adapted to engage so that when the tip of thespike pierces the seal there is essentially no dead space between saiddelivery end and the seal. Consequently, a predetermined dosage amountof medication is transferred in its entirety to the patient using thisinvention, with none of the prescribed amount being collected in deadspace in the valve. The delivery of an exact amount of medication may becritical in some situations when chemotherapeutic agents are beingadministered or small children are being treated.

As best shown in FIGS. 1 and 2, the first embodiment of valve 10,includes a valve body or housing 12, a spike element 24, and a seal 36.The seal 36 is prepared from a resilient material that is flexible,inert, impermeable to fluid, and readily pierceable by the spike 26. Inthe valve embodiment shown in FIG. 13 depicting an alternate shaped seal36d, this seal 36d has a precut slit 11 in its proximal end. Thisprovides a tiny orifice through which the tip 32 of the spike element 24may easily pass, yet still provides a fluid tight seal upon withdrawalof the spike element. These three components are assembled, as depictedin FIG. 3, with the spike element 24 enclosed to prevent accidentalsticks. FIG. 2 illustrates how the housing 12, seal 36, and spikeelement 24 are attached without the need to use any adhesive or otherbonding agent or process. Mechanical connection which provides a fluidtight closure is attained as is discussed subsequently. As shown inFIGS. 4 and 5, the seal 36 moves within the housing 12, being pierced bythe spike element 24 to expose the tip 32 of the spike element 24 toallow fluid to flow through the valve 10.

Referring to FIG. 1, one preferred embodiment of the housing 12 has abell-shaped skirt 16 and an upper, preferably cylindrical, conduit 20.The skirt 16 is integral with, and connected by an annular ring 14, tothe upper conduit 20. The skirt 16 creates a shield for an inner conduit18 of the spike element 24. This inner conduit 18 is preferablycylindrical in shape, and slightly tapered. Inner conduit 18 and upperconduit 20 comprise aligned hollow tubes so that inner conduit 18 andupper conduit 20 are in fluid communication with one another when thespike element 24 pierces the seal 36. There is an annular lip 25surrounding a circular opening 25a in the top of the conduit 20 (seeFIG. 2).

In the first embodiment of the valve, the upper conduit 20 is adapted toreceive the tip or nose 48 of an ANSI standard syringe 46 (see FIGS. 4and 5). It is, however, contemplated that the outer diameter of theupper conduit 20 can be of any size to accommodate the attachment ofother connector devices thereto. Advantageously, the proximal end of theupper conduit 20 can be equipped with a locking mechanism to facilitatelocking of the valve 10 to a variety of medical implements. For example,referring to FIG. 1, locking ears 22 near the proximal lip 25 of housing12 are preferably provided such that the housing 12 can be locked intoany compatible Luer-Lock device known to those with skill in the art.For example, referring to FIG. 19, conventional Luer-Lock threads 180can be provided on the outer diameter of upper conduit 20.

Referring to FIG. 2, the spike element 24 has at its distal end theinner conduit 18 and at its proximal end a hollow spike 26 which isintegral with the inner conduit. The inner conduit 18 and spike 26present a continuous passageway for fluid during use. An annular cuff 28on an intermediate portion of the spike element 24 is integral with, andinterconnects, the inner conduit 18 and the spike 26. As illustrated inFIG. 3, the rim 28a of the cuff 28 abuts the underside of the inner ring14, and has an annular detent 28b that snaps into an annular groove 14bin the underside of the ring. The cuff 28 serves two functions. First,it serves as an attachment device to the underside of the annular ring14. Second, it serves as a support and attachment device for the seal36.

The hollow spike 26 has a tapered conical shape, ending in a sharp,pointed tip 32. Preferably, along the length of the spike are raised,protruding ridges 30. These raised ridges 30 extend from the surface ofthe spike preferably between 0.2-2.0 mm. The ridges 30 are preferablyaligned along the length of the spike as illustrated in FIG. 2. Theseridges 30 serve to break any vacuum created when the spike 26 is sealedas described hereinbelow. Modifications to the alignment and orientationof the ridges are discussed hereinbelow in association with theirfunction. Distal the spike tip 32, there is situated at least onelongitudinal through-hole 34 to permit fluid communication between theinner conduit 18 and the upper conduit 20. Preferably, there are threethrough-holes 34 within about 10 mm and are preferably within about 5 mmfrom the spike tip 32. These through-holes 34 may be of any size,however, the larger the size of the through-holes the greater the fluidflow rate through the valve 10. In a preferred valve embodiment, thesize of the through-holes 34 are 18-gauge to provide a flow rate threetimes that of a standard 18-gauge needle.

The seal 36 preferably has a seal cap 40 with a generally flat topsurface 40b, an outwardly tapered side wall 38, and a lower lip 42. Itsinterior is hollow to provide the conically shaped cavity 37 (FIG. 3).Thus, the seal 36 slips easily over the spike element 24 to fit snuglywithin the cavity 37. The seal lip 42 is seated within the annular cuff28 and wedged between the cuff and the underside of the ring 14. Thereare longitudinal grooves 43 (FIG. 2) along the length of the seal 36which provide air pockets that facilitate compression of the seal 36during use. The grooves 43 may be of variable shape or size tofacilitate seal compression. In the first valve embodiment, there is asingle groove 43 which completely surrounds the seal 36 between the sealcap 40 and the lip 42.

The base of the seal 36 has a width such that the seal lip 42 fitssnugly into the annular cuff 28. The hollow interior or cavity 37 (FIG.3) of the seal 36 is preferably tapered to conform internally to theshape of the spike 24, having a wall portion 44 which contacts the spike24 distal seal cap 40. The exterior of the seal 36 is sized and shapedto fit inside the upper conduit 20 of the housing 12. The cap 40 resealsthe valve 10 when the top surface 40b is proximal the through-holes 34.Preferably, the cap 40 substantially fills the opening 25a in the top ofthe conduit 20. Thus, after assembly, the top surface 40b of the sealcap 40 is essentially flush with the lip 25, so that the lip 25 and sealcap 40 can be swabbed with alcohol or other disinfectant without leakageof disinfectant into the valve 10. It is important that the surface 40bbe exposed so that it may be swabbed with a disinfectant.

As best shown in FIG. 3, the spike 24, with contiguous inner conduit 18,is affixed to the housing 12 through the association of the externalpotion of annular cuff 28 and the internal portion of annular ring 14.Although not necessarily required, these two pieces may be affixed byany one of a variety of methods known to those of skill in the artincluding, but not limited to, heat sealing, glue, pressure lock,bonding or the like. The seal 36 fits into the annular cuff 28 and isheld in place by an internal lip 27 along the internal portion of theannular ring 14 of the housing 12. The length of the spike 24 is suchthat, after assembly, the tip of the spike rests below the plane definedby the lip 25 of the housing 12. Preferably, the spike tip 32 isapproximately from 0.525" to 0.1" below the lip 25 of the housing 12.The seal 36 fits snugly against the spike 24 and is essentially flushwith the lip 25 of the housing 12. The spike tip 32 is thus embeddedwithin the seal cap 40 prior to use or may be approximately 0.025"distal the seal cap 40 when the valve 10 is in the closed position. Theinner conduit 18 is partially shielded by the bell shaped skirt 16 ofthe housing 12 (see FIGS. 1-3). The inner surface of the bell shapedskirt 16 preferably has protruding threads 44 as an optional lockingmechanism for attaching a medical implement thereto. Further, othermedical devices can be pressure fit over the outer portion of innerconduit 18 without direct association with the protruding threads 44.

During use, the valve is designed to be adapted as a two-way valve. Theorientation of the valve is independent to fluid flow and dependent onthe preferred orientation of the preexisting connections. Thus, thevalve can be used as a valve connector for an intravenous central orperipheral piggyback connector in either orientation. Parenteral fluidis delivered to patients through tubing such that the liquid flows froma container through a piercing element into the patient. The containersare frequently changed or additional fluid bottles are added. The valvedisclosed herein is designed to interconnect medical implements alongthe route of fluid delivery to the patient. However, the valve is alsouseful in any environment in which a resealable fluid valve is desired.During use, a connector of the appropriate size is fitted over the innerconduit 18. Locking can be achieved by a Luer-Lock mechanism, a pressurefit or any other locking mechanisms known to those with skill in theart, as described above. Thus, in one example, fluid passes from theinner conduit 18 into the spike 26. However, fluid flow is locked inplace by the seal 36.

FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the medicalimplement connecting to the proximal end of the valve 10 is a syringe46. However, this connecting implement could be any number of medicalimplements known to those of skill in the art. The nose 48 of thesyringe 46 is placed on the seal cap 40 inside the lip 25 of the housing12. The application of pressure on the syringe 46 in the direction ofthe arrows, as illustrated in FIG. 4 creates pressure on seal cap 40.The resulting downward pressure compresses the seal 36. This pushes thetip 32 of the spike 26 through the seal cap 40 to expose thethrough-holes 34. Compression is facilitated by the grooves 38. Fluid isnow able to flow into the syringe 46, or vice versa, depending onwhether fluid is to be withdrawn from the patient or medication injectedinto the patient. FIG. 5 shows valve 10 opened by insertion of the nose48 of the syringe 46 into the opening 25a. A syringe plunger 49 in thesyringe 46 is retracted thereby creating a vacuum to draw fluid throughthe valve 10 into the syringe. For intravenous applications, the valve10 can be orientated in the position diagramed in FIGS. 4 and 5, or itcan be rotated 180° such that fluid flows in the opposite direction.

Upon removal of the syringe from the spike 26, as shown in FIG. 4, theseal 36 is free to return to its original shape and cover thethrough-holes 34. The ability of the seal 36 to return to its originalshape is determined by the resiliency of the material used to preparethe seal 36. In addition, the ability of the seal 36 to return to itsoriginal shape is facilitated by the protruding ridges 30 formed on theexternal surface of the spike. During compression, a vacuum may form inthe area between the spike 26 and the seal 36, thereby preventing theseal 36 from returning to its original position. The protruding ridges30 permit air to pass along the spike/seal interface to prevent vacuumformation and allow free return of the seal 36. The ability of the seal36 to deform reversibly and return to its original position isparticularly useful because (1) it immediately stops fluid flow throughthe valve 10, (2) it covers the recessed spike 26 to maintain itssterility, and (3) it reduces the risk that the spike couldinadvertently pierce another object or person. In addition, since thevalve 10 lacks movable parts, except for the seal, it is unlikely thatwhen the seal 36 is pushed down, the valve 10 would fail to function.

Advantageously, the through-holes 34 are located relatively low on thespike 26. Thus, the through-holes 34 are sealed relatively early in theprocess as the seal 36 returns to its original configuration when thevalve 10 is closed. In one preferred embodiment of the valve, thethrough-holes 34 are located 0.075" below the spike tip 32 (see FIG. 2).Additionally, the through-holes 34 are sealed even if the seal 36 doesnot fully return to its original configuration depicted in FIG. 4.Further, the ability of the seal 36 to return reversibly to its originalposition permits the reuse of the valve 10. Following disconnection, andbefore reuse, the surface of pierced seal cap 40 is essentially flushwith the housing 12. Thus, this flush surface can advantageously besterilized with alcohol or other surface decontaminating substances. Theskirt 16 and upper conduit 20 advantageously shield both connectionsfrom the surrounding environment to protect the sterility of theconnection. Further, both the skirt 16 and upper conduit 20 function ascollection reservoirs to prevent fluid from dripping from the valve 10during manipulation.

A cover cap (not shown) can be supplied to fit over the upper conduit 20as further protection for the seal surface between use. Such a covercap, however, is not needed to maintain sterility since the seal 36 maybe swabbed with a disinfectant after each use. The reversibility of theseal 36 makes the valve 10 particularly attractive as a connector valveto provide fluid communication between two fluid lines. Therefore, thevalve provides for placing a first fluid line in communication with asecond fluid line using the valve disclosed herein. The reversibility ofthe valve 10 permits multiple fluid lines to be successively added, forexample, to a fluid line in direct communication with a patient's vein.Since the valve is easily sterilizable and sealable, fluid lines can beadded and removed without disconnecting venous contact.

The valve 10 is preferably prepared from a hard plastic, such as ABSplastic, but it is additionally contemplated that the valve could beprepared from other medically inert materials known to those in the art.The spike element 24 is preferably prepared from the same material asthe housing 12. However, a stronger material, such as a poly-carbonatematerial, may be desirous for the spike element 24 to enable it topierce a variety of connecting septums and seals. One particularadvantage of this valve is that it does not rely on the use of metalneedles. This dramatically reduces the risk of skin puncture during useand manufacture. Further, the upper conduit 20 serves as a shield to thespike 26 such that skin contact with the spike 26 is further reduced.The spike 26 need only be strong enough to penetrate the seal cap 40, orif necessary, to pierce a connecting septum.

In the embodiment of the valve illustrated in FIGS. 2-4, thethrough-holes 34 are placed distal spike tip 32. This placement providestwo important advantages. First, the placement of the through-holes 34facilitates resealing of the valve 10 after use. Second, if thethrough-holes were placed at the spike tip 32, the holes 34 may core theseal cap 40 thereby introducing seal particulate into the fluid flow andpossibly plug the holes 34. Thus, the longitudinal placement of thethrough-holes distal the spike tip 32 prevents the introduction ofparticulates into the fluid path and/or plugging of the through-holes34. It is additionally contemplated that the number and diameter of thethrough-holes 34 can be adjusted to accommodate different fluidvelocities. In a preferred embodiment of the valve, the preferredvelocity of fluid passing through the through-holes 34 is equal to orgreater than the flow rate through an 18-gauge needle. Through-holeslarger than 18 gauge will, of course, facilitate greater fluid flowrates.

An important advantage of the valve 10 is that it has very little deadspace, thus the volume of liquid entering into the valve 10 issubstantially equivalent to the volume of fluid leaving the valve 10.Further, the total equivalent fluid volume of the valve is very smallsuch that the volume of fluid flowing through the system in order toplace the valve 10 in fluid communication with a medical implement suchas a syringe 46 is substantially zero.

In another preferred embodiment of the valve, illustrated by FIGS. 6 and7, a disposable sterile adaptor valve 50 is provided to function as aresealable lid for a container (not shown) of fluid. The fluid can thusbe removed from the fluid container or permitted to flow from thecontainer into a medical implement adapted to house fluid in a sterilemanner. As is the conventional practice, an open mouth of the containerwill ordinarily be sealed with a cover member (not shown).

FIG. 6 shows an adaptor valve 50 having a body including an adaptorskirt 52. The adaptor skirt 52 will preferably fit snugly over the openmouth of the container. The skirt 52 may be of any size to accommodate arange of container sizes. A lengthwise slit 54 is preferably provided inat least one location along the length of the skirt to ensure a snug fitbetween the skirt 52 and the container. A chamber 56, preferably tubularin configuration, extends upward from the skirt 52 and is similar inconstruction and design to the upper conduit 20 of the first preferredvalve embodiment. Similar to the first valve embodiment, the proximalportion of the valve may contain a locking mechanism 59 that preferablycomprises a Luer-Lock device or other locking device known to those ofskill in the art.

As depicted in FIG. 7, a spike 58 extends upward through a tubularchamber 56. A spike tip 60 is preferably recessed from a proximal lip 62of the tubular chamber 56. In a closed position, this tip 60 is coveredby a seal 64, which is essentially the same as seal 36. Protrudingridges 66 and seal grooves 68 facilitate seal compression and promoteclosure following use. Thus, in the closed position as illustrated inFIG. 7, the seal 64 covers the through-holes 70 to prevent fluidout-flow from the container. The adaptor valve 50 contains a secondspike 72 which points in the opposite direction as the spike 58. Thesespikes 52 and 72 are in fluid communication with each other. The spike72 extends downward inside the adapter skirt 52. The two spikespreferably form one component of the valve 50 while the skirt 52 andupper chamber form a second component. These two components can beassembled in a manner like that of the valve 10. The spike 72, like thespike 58, has longitudinal through-holes 74 and a tip 76. Thethrough-holes 74 are located inward of the tip 76. The adaptor valve 50is thus useable with containers holding sterile medicament having acover or septum seal at the open mouth of the container. Examples ofcontainers with such seals contemplated for use with this valve includedosage bottles for intramuscular injector antibiotic containers or thelike. However, it is also contemplated that the valve 50 can be adaptedwith its own seal and locking mechanism to permit the valve to beemployed on a variety of containers for medicaments or other fluids.Medicaments in these types of containers are preferably maintained understerile conditions and the volume and nature of the medicament is suchthat multiple aliquots are intermittently removed over time. If themedicament is reconstituted, then, during use, any covering over theopening on the container is removed to reveal the rubber septum. Theadaptor valve 50 is placed over the septum and direct pressure isapplied to pierce distal spike 72 through the septum and into thecontainer. A syringe or the like can then be applied, as depicted inFIG. 4, in association with the first preferred valve embodiment, towithdraw fluid from the container. The pressure of the nose 48 over thespike 58 pushes the spike tip 60 through the seal 64. At the same time,the seal 64 is compressed. Compression is accommodated by the sealgrooves 68. Fluid is withdrawn from the container and the syringe isremoved from the spike 58. Release of the pressure applied to the seal64 permits the seal 64 to return to its original configuration. Thespike ridges 66 facilitate movement of the seal 64.

Often the ingredients housed in containers are those that can belyophilized at purchase. Lyophilized ingredients require reconstitutionbefore use. If the medicament requires reconstitution before use, thensterile water, saline, or other fluid can be introduced into thecontainer before fluid is extracted. The two-way nature of the valvepermits this without any special adaptation. After the syringe isremoved, the adaptor valve 50 automatically seals. Subsequently,aliquots can be removed from the container by syringe or the like.Alcohol or other compatible surface sterilizing agents can be used towipe the lip 62 and seal 64 before each use. Similar to the first valveembodiment, it is additionally contemplated that a cap can be providedto fit over the upper chamber lip 62 between uses.

The adaptor valve 50 can be adapted to function as a medicament adaptorfor an intravenous container. In this case, the adaptor valve 50 isplaced on a medicament container for intravenous delivery and attachedvia tubing to an intravenous feed. Thus, the adaptor valve 50 can beplaced in fluid communication with a connector valve of FIG. 1 tofacilitate the flow of medicament from intravenous drip bottles.

An alternative embodiment of the seal, a seal 36a, is shown in FIG. 9.The seal 36a comprises a seal cap 92 at the proximal end thereof and aseal lip 96 at the distal end thereof. A cup-like annular flange 95 isprovided proximal the seal cap 92. The seal cap 92 and seal lip 96 areconnected by a seal wall consisting of a plurality of ringed wallportions 94 that expand and collapse in an accordion like fashion.During compression of the seal 36a, the diameter of the ringed wallportions 94 expand outward in the radial direction. There are airpockets 13a (FIG. 10) between ring portions 94 and the housing and airpockets 13b between the spike 24 and seal 36a. The seal 36a contains acavity 98 distal the seal cap 92 and adjacent the ringed wall portions94. The seal 36a interacts with the spike 26 (FIG. 2) and othercomponents of the valve in a similar fashion to the seal 36 of FIG. 2.

Referring to FIG. 10, the cup-like annular flange 95 can be stretchedaround the upper conduit 20 and held in place by an annular ring 97.This creates a trampoline-like effect that assists returning the seal36a to a decompressed state after withdrawal of a syringe (not shown).This embodiment has two advantages. First, the proximal end of the valve10 can be swabbed with alcohol or other disinfectant without leakage ofdisinfectant into the valve 10. Second, by affixing the cup-like annularflange 95 to the upper conduit 20 at the proximal end thereof with theannular ring 97, the repeated deformation and reformation of the seal36a is assisted.

In an alternative embodiment of the seal, the seal 36b is shown inconnection with the valve 10 in FIG. 11. The seal 36b is similar to theseal 36a shown in FIGS. 9 and 10, as the seal 36a is comprised of a sealcap 92, a side wall consisting of ringed wall portions 94 and a seal lip96. The seal 36a also has an outwardly extending ring 99 which is at aright angle with respect to the longitudinal axis of the valve 10. Thisring 99 is used to attach the seal 36b to the upper conduit 20.Preferably, an upper conduit annular plug 20' is inserted within theupper conduit 20 to create a tight fit between the perpendicular ring99, a ledge 101 in the upper conduit 20, and the plug 20'. The ring 99assists in the reformation of the seal 36b to enclose the spike 26 uponwithdrawal of a syringe (not shown).

As shown in FIG. 12, the cup-like annular flange 95 and ring 99 may bothbe used in connection with the valve 10, to provide the seal 36c. Thisseal 36c, provides rapid reformation upon withdrawal of a syringe (notshown) and realizes the advantages of both the seals 36a and 36b.

Another alternative embodiment of the seal, a seal 36d, is shown in FIG.13. In this embodiment, the seal 36d is comprised of a seal cap 92, aseal lip 96, and a side wall 150 comprised of circular tires 100 stackedin series one on top of an adjacent larger diameter lower tire. Thecircular tires 100 are preferably solid throughout the diameter of thecross-section thereof. These circular tires 100 will deform and reformupon, respectively, compression and decompression of the seal 36d,thereby exposing or covering a spike (not shown) as the case may be.

As mentioned above, preferably the seal 36d has a precut slit 11 in thecap 92 lying along the longitudinal axis of the valve 10. The seal cap92 has a unique configuration that insures that the slit 11 closes andis sealed upon withdrawal of a syringe (not shown) and reformation ofthe seal 36d. It includes an enlarged, internal, pressure responsivemember 200 which is integral with the seal cap 92. Between the proximalend of the side wall 150 and the member 200 is an annular space 102which is filled with the fluid in the cavity 98. This fluid is underpressure, for example at the blood pressure of the patient to which thevalve 10 is attached. Referring to FIG. 14, fluid, for example thepatient's blood, flows through the holes 34 in the spike 26, filling thecavity 102. This fluid presses against the exterior of the member 200,closing the slit 11 when the seal is decompressed as shown in FIGS. 14and 19. The pressure from this fluid creates a high pressure seal whichprevents fluid from escaping valve 10 through the slit 11. There is asemi-cylindrical annular flange tear ring 104 on the end of the member200 which advantageously extends the useful life of the seal 36d.

Preferably, there is a tear ring 104 integral with the member 200 alongthe perimeter of the internal surface the member 200, and a slightsaucer-like depression 204 in the external surface of the seal. Thepressure responsive element in the decompressed state closes any orificein the seal 36d to provide an essentially fluid-tight seal while in thedecompressed state. The pressure responsive member 200 enables the valveto maintain a fluid-tight seal even at very high pressures sometimesexperienced in medical applications, particularly when the valve 10 isconnected to a patient's artery. The center of the member 200 and theannular space 102 are coaxial with the entryway 11a to the orifice 11.The pressurized fluid fills the annular space 102 to apply pressure thatcompresses the member 200 to tightly close the entryway 11a to theorifice 11. In a preferred valve embodiment the distance from theentryway 11a to the proximal end of the seal cap 92 is from 0.500 to0.075 inches and more preferably approximately 0.100 inch.

As best illustrated in FIG. 22, the tip 32 is designed to avoid tearingthe seal. The tip 32 has three facets 210, 212, and 214 which are joinedwith each other along parting lines a, b, and c. This junction of thefacets 210, 212, and 214 frequently is ragged and will tear the seal36d. This is prevented by the parting lines a, b, and c, or junctions,being disposed within recesses 220, 222, and 224, respectively, toprovide "buried parting lines."

Another alternative embodiment of the valve 10 using the seal 36d isshown in FIG. 8 and FIGS. 19 through 21. In this embodiment, the innerwall 160 of the upper end of the conduit 20 is provided with at leastone, and preferably, a plurality of radial indentations 107. Theindentations 107 are elongated and disposed generally parallel to thelongitudinal axis of the valve 10 in a symmetrical, star-likeconfiguration. Each indentation has opposed lateral edges 162 whichengage the seal 36d upon compression of the seal 36d. The indentationsprovide space into which the seal 36d expands upon compression.

Another preferred embodiment of the seal 36h is shown in FIGS. 23through 25 and 27. In this embodiment, the seal 36h comprises a seal cap92 having a saucer-like depression 204 (FIG. 23). The seal 36h containsa slit 11 having a proximal end adjacent depression 204 and a distal end11a at the distal end of seal cap 92. Referring to FIG. 23, circulartires 100 similar to those in FIG. 13 are provided. The seal 36h has aninternal cavity 98. Further, the seal 36h preferably has a seal lip 96as discussed in more detail above.

As best shown in FIG. 8, the wall 181 of the proximal end of the upperconduit 20 is tapered inward at the same angle as the nose 48 of thesyringe 46. In accordance with ANSI standards, the taper is 0.006 inchper linear inch. The wall 182 of the syringe nose 48 bears against thewall 181 as the nose slides into the opening 25a to push the seal 36dinward compressing it and forcing the tip 32 of the spike 36 to enterthe slit 11. The seal 36d expands upon compression to fill essentiallycompletely the upper portions of the indentations 107. Some sections ofthe seal 36d are wedged between the edges 162 and other sections fillthe indentations 107. As the liquid flows through the nose 48 throughholes 34, air in the nose 48 is forced out of the nose 48 and expelledfrom the valve 10 between the walls 181 and 182. Thus, essentially theentire prescribed dosage is delivered through the valve 10 to thepatient. Fluid flows through the through-holes 34, but does not leakbetween either the seal 36d and the wall 181 or between the abuttingwalls 181 and 182.

FIGS. 15, 16, 17, and 18 depict embodiments of seals, namely, seal 36e,seal 36f, and seal 36g, which are substantially the same as the seals36a (FIG. 10), seal 36b (FIG. 11), and seal 36c (FIG. 12), except theside wall 150 employing the circular tires 100 is used in place of theaccordion wall portion 94.

Other components of the valve interact with the various embodiments ofthe seal in a similar fashion to their interaction with seal 36 of FIG.2. Prior to use of the valve 10, it is preferable that the seal caps 40or 92 be pierced centrally by a steel needle in the axial direction,precutting the seal to provide the slit 11 in order to allow for morerapid decompression and reformation of the seal upon piercing by thespike 26. The seals are advantageously formed from a material which canrepeatedly reseal and prevent fluid from flowing around the sealmaterial. The seal 36 should also be capable of being forced down andthen spring back into position to reseal the valve. Material that is toosoft will not reseal effectively; however, will not be capable ofspringing back after opening of the valve. Material that is too hardwill provide sufficient spring force; however, will not effectivelyseal. Thus, in a preferred embodiment, the seal is formed from asilicone having a hardness in the range from 30-70 Shore durometerunits, and more preferably in the range 40-50 Shore durometer units. Acure silicone polymer in the preferred hardness range is available fromWacker Silicone Corp. of Adrian, Mich. In some valve embodiments, it isdesirable to provide additional lubricity to the seal 36 to allow it tospring back and reseal more effectively. Dow Chemical Co. produces asilicone formulation with silicone oil built in to provide thisadditional lubricity.

In general, the closing of the valve 10 is provided not by the side wallof the seal 36 which immediately covers the through-holes 34, but by theseal cap 40, or seal cap 92 filling the proximal end of the cavity 98and the opening 25a. Thus, the seal caps 40 and 92 are sufficientlythick to reseal the opening 25a effectively after valve closure.However, the seal caps 40 and 92 should also be sufficiently thin toallow them to readily return to the closed position. Preferably thethickness of the caps 10 and 92 ranges between 0.075 and 0.500 inch andmore preferably may be approximately 0.100 inch.

The valve can be provided in a sterile and disposable form such thatafter its use in a given installation is exhausted, the device isdiscarded. However, as described above, in any given installation, thevalve can be reused multiple times. Since the valve does not employneedles, there is little chance that the device will inadvertently causeskin puncture. Therefore, the extra precautions required for handlingand disposing of needles is obviated. It will be apparent from thedetailed description provided herein that the valve can provide for theelimination of nearly all needles used in the medical environment. Withthe use of the valve described above, the need for all needles exceptthose that are directly input into a patient is, advantageously,eliminated.

The valve 10 is used to provide a closed, patient access system fortransferring a predetermined amount of medication from a remote sourceto the patient. The valve 10 is connected by the distal end to thepatient, for example, a vein or artery in fluid communication with thevalve. Blood fills the valve, but the seal 36d, for example, preventsany blood from leaking from the valve. The delivery end or nose 48 ofthe medical implement is inserted into the valve as depicted in FIG. 8,pushing the nose 48 against the seal to compress the seal sufficientlyto allow the tip 32 of the spike 24 to pierce the seal and enter saiddelivery end. The predetermined amount of medication in its entirety maynow be transferred through the nose 48 into the valve 10 and into thepatient. Since the nose 48 and seal 36d engage in a manner so that thetip 32 of the spike element 24, upon piercing the seal, meets the sealto avoid formation of any dead space at the interface between nose 48and the seal surface 40b. Transfer directly through the valve 10 ofessentially the entire predetermined amount of medication from thesyringe 46 to the patient, so that essentially none of saidpredetermined amount is collected in any dead space in the valve, isaccomplished. Upon withdrawing the nose 48 from the valve 10 the seal36d returns to the decompressed state to close the valve and maintainwhile in said decompressed state a fluid tight seal even at highpressures and after repeated uses.

Another alternative embodiment of the seal, a seal 36h, is shown in FIG.23. In this embodiment, the seal 36h is similar to seal 36d and iscomprised of a seal cap 92, seal lip 96, and a side wall 150 comprisedof circular tires 100 stacked in series one on top of an adjacent largerdiameter lower tire. Side wall 150 defines cavity 98. The circular tiresare preferably solid throughout the diameter of the cross-sectionthereof. These circular tires will deform and reform upon, respectively,compression and decompression of the seal 36h, thereby exposing orcovering a spike (not shown) as the case may be.

Seal 36h also has a precut slit 11 in seal cap 92 lying along thelongitudinal axis of the seal 36h. Slit 11 remains sealed when seal 36his in a decompressed state. As explained earlier, precutting the seal toprovide slit 11 allows for more rapid decompression and reformation ofthe seal upon piercing by the spike. Unlike seal 36d, however, seal cap92 of seal 36h is substantially solid without having any pressureresponsive member as is employed in seal cap 92 for seal 36d.

An alternative embodiment of the present invention using seal 36h isshown in FIG. 24. Spike 26a, residing within cavity 98 and having aproximal end with a tip 32 embedded in seal cap 92, is shown to be moretubular, and less frustoconical than the spike 26 illustrated in otherembodiments. Furthermore, the tip 32 of spike 26a is a blunt, roundedend, unlike the pointed tip of spike 26. Because the end is rounded, theseal cap is not subjected to deterioration through tearing by spike tip32. Thus a tear ring for the seal, as shown in FIG. 14 for example, isnot necessary for this embodiment.

Another feature of this embodiment is the arrangement of the spike 26awith the seal 36h when the seal 36h is in a decompressed state. In thisstate, rounded tip 32 of spike 36h is positioned to be embedded in slitentryway 11a, while slit 11 remains closed to any fluid flow. FIG. 24shows the entire rounded tip 32 in contact with the distal end of sealcap 92. Additionally, the side wall circular tire closest to theproximal end of the seal, tire 100a, contacts the side wall of spike26a. It is desirable that at least the next immediate distal circulartire, tire 100b, also be in contact with the spike 26a proximate thethrough-hole 34. Having a plurality of tires in contact with spike 26aproximal through-hole 34 prevents fluid from passing from cavity 98through the proximal end of the valve 10. Without such a design, fluidwould leak through through-hole 34, thereby applying enough fluidpressure on slit 11 to force slit 11 open while the seal is still in adecompressed state. Through-hole 34 should be distal the tires 100a,100b, which contact spike 26a, so that fluid passing throughthrough-hole 34 will not apply pressure to slit 11, and instead will beblocked by circular tires 100a and 100b creating a seal between thespike 26a and seal 36h.

During medical applications, for example when the valve 10 is connectedto a patient's artery, the patient's blood flows through the holes 34 inspike 26a, filling the area in cavity 98 distal the second tire 100b.Since the fluid residing between the first two tires, 100a and 100b, andbetween seal cap 92 and tire 100a constitutes a very small volume, thefluid cannot exert enough pressure against the seal cap to open slit 11.Pre-cut seal cap 92 is designed to remain closed up to fluid pressure of20 psi. Therefore, blood pressure will not open the valve 10.

Upon connection of the distal end of valve 10 with a patient's artery,however, as the blood pushes up against seal 36h, the fluid may forceseal cap 92 to move proximally, thereby also pushing the sidewall tires100 in the proximal direction. This pressure may permit blood to flowpast tires 100a and 100b to place pressure on the slit 11. However, dueto increased fluid pressure, the tires immediately distal first andsecond tires 100a and 100b move proximally and contact the spike 26a totake the original positions of tires 100a and 100b so as to ensure thata plurality of tires are always in contact with spike 26a. Because thesidewall tires 100 of seal 36h are designed to bow outward from theproximal to the distal end, the tires immediately distal tires 100a and100b may not be in contact with spike 26a when in their originalposition. However, as will be understood by those of skill in the art,if fluid flows through the spike 26a, through-hole 34 and into cavity 98of seal 36h, forcing the seal 36h to move in a proximal direction, tiresdistal the first tire 100a and second tire 100b will also move in aproximal direction and contact the spike 26a proximally through-hole 34strengthening the seal between the spike 26a and the seal 36h. That is,when fluid is not contained within the cavity 98 of the valve 10, onlythe first tire 100a and second tire 100b contact the spike 26a. However,once fluid is introduced into the cavity 98 of the valve 10, the seal36h may travel in a proximal direction. If this occurs, tires directlydistal second tire 100b contact seal 26a in addition to the first tire100a and second tire 100b strengthening the seal between the seal 36hand spike 26a and preventing fluid from traveling through spike 26a,through the through-hole 34 into the cavity 98 and past the tires 100 toexert pressure on the slit 11 in the seal cap 92 of seal 36h.

An alternative embodiment of the housing, housing 12a, is shown in FIG.25. In this partial cross-sectional view, housing 12a is similar tohousing 12, except for grooves 303, 304 that are provided along thelongitudinal axis of the interior wall of the upper conduit 20. Thegrooves 303, 304 are provided as fluid escape spaces to ensure that aperfect seal between the seal cap 92 and the inner wall 305 of the upperconduit 20 is not provided. The grooves 303, 304 preferably run from theproximal end of the upper conduit 20 distally past the portion of theupper conduit 20 in contact with the seal cap 92. As best seen in FIG.28, the groove 303 preferably extends from the proximal end of the upperconduit 20 of the housing 12a distally to the proximal end of the radialindentations 107.

Provision of the fluid escape spaces provides the advantage of allowingany fluid residing in the space between the seal 36h and the upperconduit 20 to exit the housing upon compression of the seal 36h.Referring to FIG. 25, during routine use of the valve 10 in transferringfluid, fluid may seep into the section of the housing 12a between theseal 36h and the walls 305 of the upper conduit 20. When this area isfilled with fluid and the seal cap 92 is compressed distally by amedical implement (not shown), the user may experience difficulty inforcing the seal cap 92 distally past the through-hole 34 of the spike26a, because the sidewall tires 100 no longer have any room within theupper conduit 20 to be compressed due to the presence of the fluid. Itis undesirable to require the user to apply extra force to compress theseal because oftentimes the user may twist the medical implement downonto the seal, leading to deterioration of the seal and eventualtearing. In addition, fluid between the seal 36h and the inner wall 305of the upper conduit 20 of the housing 12a may prevent the seal 36h fromcompressing distal the through-hole 34 of the spike 26a. As a result,the valve 10 would not function properly.

By providing grooves 303, 304 as fluid escape spaces, fluid presentbetween the seal 36h and the inner wall 305 of the upper conduit 20 ofthe housing 12a may travel proximally through the grooves 303, 304 uponcompression of the seal 36h by a medical implement (not shown). As thefluid is expelled from the valve 10 through the grooves 303, 304 at theproximal end of the housing 12a, the seal 36h may compress normallywithout use of excessive force by a user of the valve 10.

FIG. 26a is a top plan view of the valve shown in FIG. 25. Grooves 303,304 are shown in the upper conduit 20 of the housing 12a of the valve10. Importantly, when the seal 36h is compressed distally by a medicalimplement (not shown), the seal 36h does not expand into the grooves303, 304 thereby preventing fluid flow therethrough.

Another alternative embodiment for the housing, housing 12b, is shown inFIG. 29. The housing 12b employs a channel 307 as a fluid scape spacewhich is substantially perpendicular to the longitudinal axis of thevalve 10. A channel 307 is a bore that runs transversely through theside of the wall of the upper conduit 20, and is positioned distal toany Luer Lock threads 309 or other locking mechanism that may surroundthe upper conduit 20 near its proximal end. Similar to the grooves 303,304, the channel 307 provides a passageway for fluid within the areabetween the seal 36 and the inner wall 305 of the upper conduit 20 toexit when the sidewall tires 100 are compressed and expand into theradial indentations 107. Since an avenue exists for the fluid to exitthis area, a user does not have to apply excessive force in pushing amedical implement (not shown) distally into the valve 10.

FIG. 26b is a top plan view of the valve 10 shown in FIG. 29. Thechannel 305 is shown in phantom and is preferably located in the upperconduit 20 of the housing 12b of the valve 10. Upon compression of theseal 36h by a medical implement (not shown), fluid between the upperconduit 20 and the seal 36h is expelled from the valve 10 through thechannel 307 and out the side wall of the upper conduit 20. Thus, achannel 307 can be discharged from a groove by its injection of fluidthrough a side wall, rather than the proximal end of the housing 12a, asfor a groove 303.

As will be easily understood by those of skill in the art, a channel andgroove may be incorporated in combination to assist in expelling fluidfrom the valve upon compression of the seal by a medical implement. Forexample, upon compression of the seal, fluid could travel through agroove proximally and thereafter through a channel in communication withthe groove. The channel could be located distally the proximal end ofthe valve. Moreover, a single groove or channel may be utilized ormultiple grooves or channels may be incorporated into the valve of thepresent invention as will be easily understood by those of skill in theart.

Lack of a channel or groove as discussed above, may result indeterioration of the seal 36 and prevent the seal cap 92 from beingpushed completely below through-hole 34. If the through-hole is notcompletely open, the patient will not be able to receive a constant flowrate of medication. In some situations, the delivery of an exact amountof medication at a predetermined rate may be critical for treatment,and, therefore, through-hole 34 must be completely open for passage ofmedication from the medical implement. The groove and/or channel ensuresthat the seal cap may be pushed distally the through-hole and that theseal may be compressed without any excessive force which may causedamage to the seal.

What is claimed is:
 1. A medical valve comprising:a body including awall structure defining an internal cavity, said body having a proximalend and a distal end, said proximal having an opening sufficiently largeto receive a tip of a delivery end of a medical implement whichtransfers fluid through said delivery end; a spike having a tipcontained within said cavity, said spike having a first hole locateddistal said tip, a second hole located distal said first hole, and apassageway in communication with said first and second holes that allowsfluid to flow through said spike; and a resilient seal in said cavitysurrounding said spike, said seal adapted to be moved into a compressedstate upon insertion of the tip of the medical implement into saidopening, said seal being sufficiently resilient to return to adecompressed state upon removal of the tip of the medical implement fromsaid opening, said seal in the decompressed state being in contact withsaid spike in at least two spaced-apart points along said spike proximalsaid first hole preventing flow of the fluid through said valve whensaid seal is in a decompressed state.
 2. The valve in accordance withclaim 1, wherein said fluid exerts a first, low pressure on said sealand further wherein said seal is in contact with said spike in at leastone additional spaced-apart point along said spike proximal said firsthole when said fluid exerts a second, higher pressure on said seal. 3.The valve in accordance with claim 1, wherein said seal extends oversaid tip when in its decompressed state.
 4. A method of transferringfluid through a medical valve, said valve having a body with an internalcavity having a proximal end and a distal end, said proximal end havingan opening sufficiently large to receive a delivery end of a medicalimplement which transfers fluid through said delivery end, a spikewithin said cavity, said spike having a spike tip at the proximal endthereof, a first hole distal said spike tip and a second hole distalsaid first hole for permitting fluid to flow through said spike, and aresilient seal within said cavity of said body between said body andsaid spike, said seal in contact with said spike in at least twospaced-apart points along said spike proximal said first hole to preventflow of the fluid through said valve when said seal is in a decompressedstate, said method comprising the steps of:(a) inserting a tip of amedical implement into said opening in the proximal end of said body;(b) compressing said seal in the distal direction by applying a force tothe medical implement; (c) placing said hole and said medical implementin fluid communication; (d) transferring the fluid through said medicalvalve; (e) removing said medical implement from said opening in theproximal end of said body; and (f) permitting said seal to contact saidspike proximal said first hole, thereby preventing the flow of the fluidthrough said valve.
 5. The method of claim 4, wherein step (f) isperformed after step (e).
 6. The method of claim 3, wherein in step (f)said fluid exerts a first, low pressure on said seal, and wherein saidmethod additionally comprises:(g) said fluid exerting a second, higherpressure on said seal, wherein said seal contacts said spike in at leastone additional spaced apart point along said spike proximal said firsthole.
 7. The method of claim 4, wherein a top end of said seal extendsover said tip of said spike when said seal is in a decompressed state,and wherein in said compressing step said tip of said spike is extendedthrough said top end of said seal.